Cleared Special

K092825 - APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER

K092825 is an FDA 510(k) clearance for APEX SPINE SYSTEM 5.50 MM TITANIUM ROD ..., manufactured by Spinecraft, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 186-day FDA review.

K092825 · Spinecraft, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
186d
Days
Class 2
Risk

K092825 is an FDA 510(k) clearance for the APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spinecraft, Inc. (Westchester, US). The FDA issued a Cleared decision on March 16, 2010 after a review of 186 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092825

510(k) Number K092825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date March 16, 2010
Days to Decision 186 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 122d · This submission: 186d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 418
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K092825.
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · Nuvasive, Inc. · Jun 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · Alphatec Spine, Inc. · Jun 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · Lanx, Inc. · Apr 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · Pioneer Surgical Technology · Feb 2010
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534 · K2m, Inc. · Dec 2009
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656 · Lanx, Inc. · Nov 2009
K092825 · APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
Download PDF FDA Summary Spinecraft, Inc.